Duns Number:070637129
Device Description: VALVE, BOTTOM, DRAIN, URINE COLLECTION, STANDARD, REUSABLE, REPLACEMENTReplacement Bottom VALVE, BOTTOM, DRAIN, URINE COLLECTION, STANDARD, REUSABLE, REPLACEMENTReplacement Bottom Drain Valve for all Urocare Latex Urine Collection Leg Bags and Male Urinal sheaths. Includes Gasket-Ring #5999 preassembled.
Catalog Number
6004
Brand Name
Urocare® Standard Bottom Drain Valve
Version/Model Number
6004
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KNX
Product Code Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Public Device Record Key
219f71cc-32c8-459b-97d9-0a5e67495b75
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 11, 2018
Package DI Number
10792293060041
Quantity per Package
10
Contains DI Package
00792293060044
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 140 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |